Tina-quant Cystatin C Gen.2 6600263190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630932405), received between Aug 29, 2023 and Dec 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT CYSTATIN C GEN.2 ASSAY ON A COBAS 8000 C702 MODULE, NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS. INITIAL RESULT: 8.66 MG/L (ACCOMPANIED BY A DATA FLAG). THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. RERUN RESULT: 11.90 MG/L (ACCOMPANIED BY A DATA FLAG).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801332 ↗
• MalfunctionNov 8, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CYSC TINA-QUANT CYSTATIN C RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CYSC RESULT WAS 7.95 MG/L ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT CORRESPOND WITH THE PATIENT'S CREATININE RESULT. THE SAMPLE WAS REPEATED IN DECREASE MODE AND THE RESULT WAS 9.09 MG/L. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 7.96 MG/L ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. A 1:3 DILUTION OF THE SAMPLE WAS PERFORMED AND THE RESULT WAS 1.60 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641191 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT CYSTATIN C GEN. 2 AND CREATININE JAFFÉ GEN. 2 RESULTS FOR 1 PATIENT ON A COBAS 8000 C 701 MODULE THAT WERE USED TO CALCULATE THE (GFR) GLOMERULAR FILTRATION RATE. THE ALLEGED CALCULATED RESULTS DID NOT FIT THE CLINICAL STATUS OF THE PATIENT. SAMPLE 1: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.65 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 19.9 ML/MIN. SAMPLE 2: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.38 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 22.9 ML/MIN. THE CREATININE RESULT WAS 0.88 MG/DL. THE CALCULATED (EGFR) GLOMERULAR FILTRATION RATE WAS 72 ML/MIN. SAMPLE 3: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.07 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 27.6 ML/MIN. THIS MEDWATCH WILL APPLY TO THE TINA-QUANT CYSTATIN C GEN. 2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CREATININE ASSAY. THE SAMPLES WERE REPEATED DUE TO THE PATIENT HAVING NO KNOWN ILLNESSES AND DID NOT TAKE ANY MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416204 ↗
• MalfunctionAug 29, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT CYSTATIN C GEN. 2 (CYSC2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR COMPLAINED THAT THE RESULT DID NOT MATCH THE PATIENT'S HISTORY AND HEALTH STATUS AND THE REST OF THE DIAGNOSTIC TEST RESULTS, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPORTER ALSO SERIALLY DILUTED THE PATIENT SAMPLE WITH 0.9% NACL MANUALLY TO CHECK FOR ANY INTERFERENCE. ON (B)(6) 2023: - THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 6.25 MG/L. ON (B)(6) 2023: - THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 6.35 MG/L. - THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:16 DILUTION WAS 0.00 MG/L. - THE THIRD REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:8 DILUTION WAS 0.10 MG/L WITH A FINAL DILUTION RESULT OF 0.80 MG/L. - THE FOURTH REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:4 DILUTION WAS 0.31 MG/L WITH A FINAL DILUTION RESULT OF 1.24 MG/L. - THE FIFTH REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:2 DILUTION WAS 1.42 MG/L WITH A FINAL DILUTION RESULT OF 2.84 MG/L. - THE SIXTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 6.59 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641221 ↗